Jazz Pharmaceuticals Plc Stock Price, News & Analysis

Jazz Pharmaceuticals announced that zanidatamab-hrii (Ziihera®) has been included in the NCCN Clinical Practice Guidelines as a category 2A treatment option for Biliary Tract Cancers (BTC). The drug, which received FDA accelerated approval on November 20, 2024, is now commercially available in the United States.

Ziihera is the first and only FDA-approved dual HER2-targeted bispecific antibody for HER2+ (IHC 3+) BTC. The approval was based on the HERIZON-BTC-01 clinical trial results, which showed a 52% objective response rate and median duration of response of 14.9 months. The drug is indicated for adults with previously treated, unresectable or metastatic HER2-positive BTC.

Jazz Pharmaceuticals (Nasdaq: JAZZ) announced a webcast scheduled for December 11, 2024, at 4:30 p.m. ET to discuss Ziihera® (zanidatamab-hrii), their recently approved chemotherapy-free dual HER2-targeted bispecific antibody for biliary tract cancer (BTC). The presentation will cover clinical data, patient needs, and commercialization strategy.

The FDA granted accelerated approval to Ziihera on November 20, 2024, for treating adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) BTC. Dr. Shubham Pant from MD Anderson Cancer Center will discuss data from the HERIZON-BTC-01 trial during the webcast.

Jazz Pharmaceuticals (JAZZ) announced presentations at two major medical conferences: the 2024 San Antonio Breast Cancer Symposium (SABCS) and the 66th American Society of Hematology (ASH) Annual Meeting. At SABCS, the company will present two abstracts focusing on Ziihera® (zanidatamab-hrii), including a Phase 3 trial design and new data from a Phase 1b/2 study in HER2-positive breast cancer patients.

At ASH, Jazz will showcase 13 abstracts, primarily featuring research on Vyxeos® and Defitelio®. The presentations include multiple Phase 3 trials and studies examining various combination therapies for acute myeloid leukemia (AML) and other blood cancers. This extensive research portfolio demonstrates Jazz's commitment to advancing cancer treatment options.

Jazz Pharmaceuticals announced FDA accelerated approval of Ziihera (zanidatamab-hrii) for treating adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC). The approval is based on the HERIZON-BTC-01 trial results showing a 52% objective response rate and 14.9 months median duration of response. Ziihera is the first dual HER2-targeted bispecific antibody approved for HER2+ BTC in the U.S. The Phase 3 HERIZON-BTC-302 confirmatory trial is ongoing, and continued approval may be contingent upon verification of clinical benefit.

Jazz Pharmaceuticals (Nasdaq: JAZZ) has announced its participation in Citi's 2024 Global Healthcare Conference. The company's management will engage in a fireside chat on December 3, 2024, at 7:15 a.m. PT / 10:15 a.m. ET / 3:15 p.m. GMT. An audio webcast will be available through the company's investor website and archived for 30 days.

Jazz Pharmaceuticals is a global biopharma company focusing on developing life-changing medicines for serious diseases. The company maintains a diverse portfolio of marketed medicines for sleep disorders and epilepsy, along with cancer treatments. Based in Dublin, Ireland, Jazz operates research, development, and manufacturing facilities across multiple countries.

Jazz Pharmaceuticals announced its Q3 2024 financial results, reporting a 14% year-over-year revenue increase driven by key products Xywav, Epidiolex, and Rylaze. The company affirmed its 2024 total revenue guidance of $4.0 to $4.1 billion.

Key highlights include:

• Record revenues of over $1.05 billion.
• Strong demand for Xywav with 400 net patient additions.
• Anticipated launch of Zanidatamab for BTC in Q4 2024.
• Plan to submit sNDA for Zepzelca in 1H 2025.

Financial highlights show a GAAP net income of $215.1 million and a non-GAAP adjusted net income of $416.9 million. The company completed a $1 billion senior notes offering and repurchased $150 million of its shares.

Jazz Pharmaceuticals Iberia has achieved remarkable recognition by ranking 15th among the 100 Best Companies to Work For in Spain, marking a significant improvement from its 71st position last year. The company ranks as the third-highest pharmaceutical company on the list. This recognition comes from business magazine Actualidad Económica, which bases its annual ranking on a comprehensive questionnaire developed with HR experts, evaluating categories including Talent Management, Remuneration and Compensation, Environment, Corporate Social Responsibility, and Training.

Jazz Pharmaceuticals (JAZZ) presented eight abstracts at Psych Congress 2024, featuring top-line results from the Phase 4 DUET trial evaluating Xywav in adults with narcolepsy or idiopathic hypersomnia (IH). The trial demonstrated statistically significant improvements in excessive daytime sleepiness and sleep disruption for narcolepsy patients, with ESS score changes of -7.7. For IH patients, the trial showed improvements in ESS (-8.4) and IHSS (-15.5) scores, with 94.6% of participants reporting overall improvement. The most common adverse events included nausea, dizziness, and headache, consistent with Xywav's known safety profile.

Jazz Pharmaceuticals (Nasdaq: JAZZ) has announced it will release its 2024 third quarter financial results on Wednesday, November 6, 2024, after U.S. market close. The company will host a live audio webcast at 4:30 p.m. ET to discuss the results and provide business updates. Interested parties can access the webcast through Jazz's investor relations website, with registration recommended 15 minutes before the event. The company, headquartered in Dublin, focuses on developing medicines for sleep disorders, epilepsy, and cancer treatments.